The Centers for Medicare and Medicaid Services has finalized coverage of Next Generation Sequencing for cancer patients.
The advanced genomic diagnostic laboratory FDA-approved tests are now covered by Medicare.
CMS has approved the innovative personalized medicine as a national coverage determination for patients with advanced cancer such as recurrent, metastatic, relapsed, refractory, or stages III or IV cancer.
When these tests are used as a companion diagnostic to identify patients with certain genetic mutations, they can assist patients and their oncologists in making more informed treatment decisions, CMS said.
Additionally, when a known cancer mutation cannot be matched to a treatment then results from the diagnostic lab test using NGS can help determine a patient’s candidacy for cancer clinical trials.
The decision was made following the parallel review with the FDA, which granted its approval of the FoundationOne CDx test on Nov. 30, 2017.
F1CDx is the first breakthrough-designated, Next Generation Sequencing-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies. It can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.
“We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,” said Seema Verma, CMS Administrator. “That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.”
Source: Healthcare Finance News